Recon: EMA recommends Valneva COVID vaccine; Novartis wins FDA approval for Tafinlar + Mekinist combo

ReconRecon | 23 June 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Biogen, citing insurance challenges, shutters one of its Aduhelm studies (BioPharmaDive)
  • U.S. FDA labels Baxter's respiratory device recall as most serious (Reuters)
  • Novartis wins U.S. approval for targeted cancer drug combination (Reuters)
  • Despite fanfare, the FDA’s step toward lowering nicotine levels in cigarettes is a very early one (STAT)
  • U.S. FDA halts sales of Juul e-cigarettes in nicotine crackdown (Reuters)
  • New Senate proposal to lower insulin prices would let drugmakers lock in their current profits (STAT)
  • FDA probes one more infant death potentially related to Abbott baby formula (Reuters)
In Focus: International
  • EU watchdog backs Valneva's COVID shot as contract talks go on (Reuters) (EMA)
  • EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17 (EMA)
  • WHO eyes decision on monkeypox 'emergency', Africa says it's long overdue (Reuters)
  • Smallpox drugmakers get new orders as monkeypox spreads (Reuters)
  • GSK, Novartis pledge funds for diseases that mostly affect the poor (Reuters) (Fierce)
  • Uniqure’s Huntington’s gene therapy lowers key protein in small trial (STAT) (Fierce)
  • Africa must end food, pharma import dependence, AfDB president says (Reuters)
  • BioNTech breaks ground on first mRNA vaccine manufacturing facility in Africa (Endpoints)
  • AstraZeneca continues to build out its presence in China with new COPD drug manufacturing site (Endpoints)
  • Clinical management of COVID-19: Living guideline, 23 June 2022 (WHO)
Pharma & Biotech
  • The Quality Lowdown: US FDA Renews Attention To Contamination Challenges (Pink Sheet)
  • Indonesia to buy 29 mln foot and mouth disease vaccine doses as outbreak worsens (Reuters)
  • FDA warns Mexican glycerin manufacturer for refusing an inspection (Endpoints)
  • Pfizer donates first $5M in Russian profits since the war started to help Ukrainians (Endpoints)
  • AstraZeneca debuts first consumer campaign for its Covid-19 prophylactic Evusheld — and a first for EUA drugs (Endpoints)
  • F-star bought out in $161M all-cash deal as Hong Kong's Sino Biopharm looks toward international expansion (Endpoints)
  • Xenon jumps on positive data-to-immediate public offering train to bankroll PhIII epilepsy study (Endpoints)
  • MilliporeSigma looks to keep up with the competition in new Wisconsin expansion (Endpoints)
  • Patient death prompts another recall of Medtronic’s HVAD System (MedtechDive)
  • Wearables are collecting a flood of data. An ambitious new study of pregnancy aims to prove that’s valuable for health (STAT)
  • BD recalls two years’ worth of bone marrow needle kits after 37 complaints (Fierce)
  • Bioventus agrees to staggered payment plan to close stalled $315M CartiHeal takeover (MedtechDive)
  • FDA Plans Meeting On Pulse Oximeter Accuracy (MedtechInsight)
  • French Company Gets FDA Breakthrough Status For Brain Device (MedtechInsight)
Government, Regulatory & Legal
  • Fight over where to house ARPA-H still brews with House bill's passage (Endpoints)
  • Congress lays out its demands for FDA in 2023 — on everything from machine learning to immunotherapies (Endpoints)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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